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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214679
Company: AZURITY

Medication Guide

Products on NDA 214679

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPRONTIA	TOPIRAMATE	25MG/ML	SOLUTION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214679

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/05/2021	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214679s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214679Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214679Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/06/2026	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214679s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214679Orig1s012ltr.pdf
03/12/2025	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214679s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214679Orig1s009ltr.pdf
05/17/2024	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214679s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214679Orig1s007ltr.pdf
10/26/2022	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214679s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214679Orig1s002ltr.pdf

Labels for NDA 214679

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/06/2026	SUPPL-12	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214679s012lbl.pdf
03/06/2026	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214679s012lbl.pdf
03/12/2025	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214679s009lbl.pdf
05/17/2024	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214679s007lbl.pdf
05/17/2024	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214679s007lbl.pdf
10/26/2022	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214679s002lbl.pdf
10/26/2022	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214679s002lbl.pdf
10/26/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214679s002lbl.pdf
11/05/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214679s000lbl.pdf

Therapeutic Equivalents for NDA 214679

EPRONTIA

SOLUTION;ORAL; 25MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPRONTIA	TOPIRAMATE	25MG/ML	SOLUTION;ORAL	Prescription	Yes	AB	214679	AZURITY
TOPIRAMATE	TOPIRAMATE	25MG/ML	SOLUTION;ORAL	Prescription	No	AB	217795	ALKEM LABS LTD

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